14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
10M - The Braun Corp.10311-WI
FDA UDI
Certified Safety Manufacturing, Inc.·00766588095387·10M - The Braun Corp.10311-WI
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981197483·Smooth Shank Poly. Screw, 3.5mm x 38mm
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
FDA 510(k)
FDA Class 2
·General Hospital
TDP CQ-27 HEAT LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
Gibralt
FDA UDI
Choice Spine, LP·10885862247575·
Gibralt®
FDA UDI
INNO Holdings, Inc.·M711050002035380·Posterior Cervical Screw Assembly, 3.5mm X 38mm...
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 27, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013
VASSALLO GT
FDA Adverse Event
Injury
·FILMECC CO., LTD.·Product code DQX·October 3, 2024
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012